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Vistagen Broadens PH80 Global Intellectual Property Portfolio with New Patents for the Treatment of Migraine

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Vistagen (Nasdaq: VTGN), a clinical-stage biopharmaceutical company, announced new patents for PH80, a non-systemic nasal spray aimed at treating migraines. These patents extend Vistagen's global intellectual property portfolio across Australia, Hong Kong, Japan, and Mexico, supplementing previously granted U.S. and EPO patents. The new patents are effective until 2040, with potential for extensions. PH80 is also being developed for menopause-related hot flashes and other conditions.

Positive
  • Vistagen received multiple new patents for PH80, enhancing its global intellectual property portfolio.
  • The patents cover Australia, Hong Kong, Japan, and Mexico, supplementing existing U.S. and EPO patents.
  • Patents are effective until 2040, subject to extensions.
Negative
  • None.

The issuance of new patents for Vistagen's PH80 nasal spray in multiple countries like Australia, Hong Kong, Japan and Mexico extends the company's intellectual property (IP) protection until at least 2040. This development significantly strengthens Vistagen's competitive position in these regions by preventing generic manufacturers from entering the market with similar products. Patents play a important role in safeguarding innovation and enabling companies to recoup research and development investments. By extending their IP portfolio, Vistagen also improves its leverage in potential licensing deals or partnerships, enhancing its long-term revenue prospects.

However, investors should note that while expanded IP protection is a positive step, it does not guarantee commercial success. The company must still successfully navigate clinical trials, regulatory approvals and market competition.

For retail investors, these new patents represent a form of risk mitigation, securing the company's future revenue streams in the event that PH80 becomes a commercial success.

Vistagen's PH80 is described as a non-systemic, hormone-free investigational pherine nasal spray targeting rapid-onset relief for migraines and other conditions. The non-systemic and hormone-free aspects are particularly noteworthy because they imply fewer systemic side effects, which often plague systemic migraine medications. This can be an appealing factor for both patients and healthcare providers, potentially enhancing market adoption if the product proves effective in clinical trials.

From a long-term perspective, the success of PH80 in clinical trials could disrupt the migraine treatment market by offering a novel, fast-acting option. However, investors should be cautious and follow ongoing clinical trial results closely, as the efficacy and safety of the treatment remain to be fully validated.

Understanding the unique mechanism of action and its potential advantages can be enlightening for investors, as it provides context for the company's claims and future potential.

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Vistagen (Nasdaq: VTGN), a clinical-stage neuroscience-focused biopharmaceutical company dedicated to the development and commercialization of groundbreaking therapies for psychiatric and neurological disorders based on nose-to-brain neurocircuitry, today announced the broadening of its global intellectual property portfolio after receiving multiple new patents related to the use of PH80 for the treatment of migraine. PH80 is a non-systemic, hormone-free investigational pherine nasal spray in development as a rapid-onset treatment for vasomotor symptoms (hot flashes) due to menopause, with the potential to also treat premenstrual dysphoric disorder, dysmenorrhea, and migraine.

The new patents complement previously granted PH80 U.S. Patent No. 11,419,881 and EPO Patent No. 3955933 for the treatment of migraine. All of the new patents are expected to be in effect until 2040, subject to possible patent term extensions on a country-by-country basis.

  • Australia: IP Australia issued a Notice of Allowance;
  • Hong Kong: The Hong Kong Special Administrative Region – Intellectual Property Department issued Patent No. 40068177;
  • Japan: The Japan Patent Office issued Patent No. 7476229; and
  • Mexico: The Mexican Institute of Industrial Property issued a Notice of Allowance.

About PH80 Nasal Spray

PH80 is an investigational neuroactive pherine nasal spray with a novel neurocircuitry-focused mechanism of action (MOA) that is fundamentally differentiated from all currently approved treatment options for women’s health indications. PH80’s proposed MOA does not require systemic absorption or direct activity on neurons in the brain. Vistagen is developing PH80 as a potential new hormone-free treatment for the management of vasomotor symptoms (hot flashes) due to menopause, with additional potential in premenstrual dysphoric disorder, migraine, and dysmenorrhea.

About Pherines

Pherines are a novel class of synthetic neurocircuitry-focused drug candidates for psychiatric and neurological disorders. They are odorless and tasteless neuroactive steroids, delivered only intranasally, each with a differentiated mechanism of action (MOA) and safety profile from all currently approved drugs. Our neuroactive pherines rapidly activate olfactory system neurocircuitry to achieve therapeutic effects via nose-to-brain neural connections. Through these connections, pherines activate neural circuitry to specific brain regions that impact the neuroscience disorders we are targeting, without requiring systemic absorption or central nervous system (CNS) uptake. As a result of their novel non-systemic MOAs, our pherine drug candidates have demonstrated favorable and differentiated safety profiles in all clinical trials completed to date.

About Vistagen

Headquartered in South San Francisco, CA, Vistagen (Nasdaq: VTGN) is a clinical-stage neuroscience-focused biopharmaceutical company dedicated to the development and commercialization of groundbreaking therapies for psychiatric and neurological disorders based on its pioneering approach and deep understanding of nose-to-brain neurocircuitry. Designed exclusively as nasal sprays administered at microgram level doses, Vistagen’s diversified pipeline of pherine product candidates rapidly activate chemosensory neurons in the nasal cavity to impact olfactory system and brain neurocircuitry. Favorable safety profiles have been observed in all clinical studies of Vistagen’s pherine product candidates completed to date. Vistagen’s neuroscience pipeline also includes an oral prodrug with the potential to modulate NMDA receptor activity in multiple neurological conditions, such as levodopa-induced dyskinesia associated with Parkinson’s disease therapy and neuropathic pain. At Vistagen, we are passionate about creating novel and differentiated treatments that set new standards of care for millions of people living with anxiety, depression, and other neurological disorders. Connect at www.Vistagen.com.

Forward-looking Statements

This press release contains certain forward-looking statements within the meaning of the federal securities laws. These forward-looking statements involve known and unknown risks that are difficult to predict and include all matters that are not historical facts. In some cases, you can identify forward-looking statements by the use of words such as “may,” “could,” “expect,” “project,” “outlook,” “strategy,” “intend,” “plan,” “seek,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “strive,” “goal,” “continue,” “likely,” “will,” “would” and variations of these terms and similar expressions, or the negative of these terms or similar expressions. Such forward-looking statements are necessarily based upon estimates and assumptions that, while considered reasonable by Vistagen Therapeutics, Inc. (Vistagen or the Company) and its management, are inherently uncertain. As with all pharmaceutical products, there are substantial risks and uncertainties in the process of development and commercialization and actual results or development may differ materially from those projected or implied in these forward-looking statements. Among other things, there can be no guarantee that the scope of protection and enforceability provided by any patents issued for any of the Company’s drug candidates, including PH80, will be sufficient to deter competition, or that any of the Company’s drug candidates, including PH80, will successfully replicate past preclinical studies and/or clinical trials, complete ongoing or future clinical trials, receive regulatory approval or be commercially successful. Other factors that may cause such a difference include, without limitation, risks and uncertainties relating to delays in launching, conducting and/or completing ongoing and planned nonclinical studies and clinical trials; the period over which the Company anticipates its available financial resources will fund its operating expense; the timing of completion of preclinical studies and clinical trials and related preparatory work required to apply for and maintain regulatory approval for any of our product candidates; fluctuating costs of materials and other resources and services required to conduct the Company’s ongoing and/or planned clinical and nonclinical trials; market conditions; the impact of general economic, industry or political conditions in the United States or internationally; and other technical and unexpected hurdles in the development, manufacture and commercialization of the Company’s product candidates. These risks are more fully discussed in the section entitled "Risk Factors" in the Company’s most recent Annual Report on Form 10-K for the fiscal year ended March 31, 2024, as well as discussions of potential risks, uncertainties, and other important factors in our other filings with the U.S. Securities and Exchange Commission (SEC). The Company’s SEC filings are available on the SEC’s website at www.sec.gov. Additionally, you should not place undue reliance on these forward-looking statements in the future, because they apply only as of the date of this press release and should not be relied upon as representing the Company’s views as of any subsequent date. The Company explicitly disclaims any obligation to update any forward-looking statements, other than as may be required by law. If the Company does update one or more forward-looking statements, no inference should be made that the Company will make additional updates with respect to those or other forward-looking statements.

Investors:

Mark A. McPartland

Vistagen Therapeutics

markmcp@vistagen.com

Media:

Caren Scannell

Vistagen Therapeutics

cscannell@vistagen.com

Source: Vistagen

FAQ

What is the significance of Vistagen's new patents for VTGN?

Vistagen's new patents for PH80 expand its global intellectual property portfolio, covering Australia, Hong Kong, Japan, and Mexico. This strengthens the company's position in the treatment of migraines and other conditions.

When are the new patents for VTGN's PH80 effective until?

The new patents for VTGN's PH80 are effective until 2040, with the possibility of patent term extensions on a country-by-country basis.

Which countries have granted new patents for VTGN's PH80?

New patents for VTGN's PH80 have been granted in Australia, Hong Kong, Japan, and Mexico.

What conditions is VTGN's PH80 being developed to treat?

VTGN's PH80 is being developed to treat migraines, menopause-related hot flashes, premenstrual dysphoric disorder, and dysmenorrhea.

Vistagen Therapeutics, Inc.

NASDAQ:VTGN

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Biotechnology
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